Yoga for Persistent Fatigue in the Survivors of Bone Marrow Transplantation: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Practice log
研究概览
简要总结
Cancer-related fatigue (CRF) after hematopoietic cell transplantation (HCT) is a persistent problem that limits activities and causes distress. Considering the high prevalence of CRF among HCT survivors and the limitations of currently existing treatments, there is a pressing need for establishing safe and effective options for reducing CRF after HCT. Based on evidence supporting the use of yoga for CRF in non-HCT populations, yoga is one option worthy of evaluation for ameliorating CRF in HCT patients. Yoga is easy to implement, may be appealing to HCT patients, and can be self-administered, which would encourage long-term use and potentially lead to a better control of persistent CRF in HCT survivors. The primary aim of the proposed study is to assess the feasibility of a yoga intervention for HCT survivors with CRF. Outcomes from this feasibility study will provide the information needed to design a larger, adequately powered randomized controlled trial to evaluate yoga for CRF in HCT survivors. This study will employ a mixed-methods, single-arm, pretest-posttest design with focus groups. Twenty HCT survivors who report at least moderate fatigue will be recruited from the HCT clinic, Michigan Medicine. Participants will be enrolled in a six-week Restorative yoga program. The program will consist of a weekly, 60-minute yoga group class led by a certified yoga instructor along with twice-weekly home practice using yoga DVD.
详细描述
OBJECTIVES
Primary Objective: To assess the feasibility of an organized yoga intervention for HCT survivors with CRF.
Hypothesis: A trial of yoga in the HCT survivor population will be deemed feasible if at least 75% of study subjects demonstrated protocol adherence rate of at least 80%.
Secondary Objectives:
- Explore participants' perceptions regarding yoga and physical activity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult HCT survivors as defined by being at least 100 days post autologous or allogeneic transplantation for a malignant disease. There is no restriction to enrollment by donor type, donor cell source, presence or absence of graft versus host disease.
- •Age ≥ 18 years at the time of transplant.
- •A history of persistent CRF as defined by a perception of general CRF for at least one month before enrollment.
- •A history of at least moderate CRF as defined by a CRF score of 4 or more on a 10-point Visual Analog Scale.
- •Participants who are deemed qualified for yoga movements according to the Yoga Qualifying Movements Screening Checklist (a checklist developed by researchers at the University of California, Los Angeles to promote yoga safety through assessing the eligibility of each patient)
排除标准
- •A self-reported current practice of yoga or any other mind-body therapy, including but not limited to meditation or hypnosis therapy in the past 30 days prior to study enrollment.
- •Subjects currently on supplemental oxygen support.
- •Subjects currently receiving hemodialysis.
- •Subjects currently admitted to an inpatient unit at Michigan Medicine.
- •Subjects with an uncontrolled, active infection. Subjects with viremia (Cytomegalovirus or other) may be enrolled, provided they are on active therapy and at the discretion of the treating physician.
- •Subjects who have relapsed after their autologous or allogeneic transplant.
研究组 & 干预措施
Yoga arm
A six-week restorative yoga intervention consisting of a weekly, 60-minute yoga group class led by a certified yoga instructor along with twice-weekly home practice using yoga DVD.
干预措施: Yoga (Behavioral)
结局指标
主要结局
Practice log
时间窗: Weekly during the six-week intervention period
Yoga practice at home will be documented on a log sheet to be filled out by participants at the end of each practice week. We will check class attendance during the weekly telephone call with the study participants. We will use a log sheet to document in-class yoga practice and location of the yoga performance. At the end of the program, the number of yoga practice hours per participant will be tabulated. This number will be used to evaluate participants' adherence to yoga practice.
次要结局
- Side-effects/adverse events log(Weekly during the six-week intervention period)
- PROMIS-SF-depression(At baseline (before treatment) and within 10 days of the last in-class yoga session)
- PROMIS-SF-sleep disturbance(At baseline (before treatment) and within 10 days of the last in-class yoga session)
- Self-Efficacy for Managing Chronic Disease Scale(At baseline (before treatment) and within 10 days of the last in-class yoga session)
- electronic pedometer(At baseline (before treatment) and within 10 days of the last in-class yoga session)
- Multidimensional Fatigue Symptom Inventory(At baseline (before treatment) and within 10 days of the last in-class yoga session)
- PROMIS-SF-Fatigue(At baseline (before treatment) and within 10 days of the last in-class yoga session)
- Brief Pain Inventory - Short Form(At baseline (before treatment) and within 10 days of the last in-class yoga session)
- Index of Self-Regulation Scale(At baseline (before treatment) and within 10 days of the last in-class yoga session)
- PROMIS-SF- physical function(At baseline (before treatment) and within 10 days of the last in-class yoga session)
研究者
Mohamad Baydoun
PhD Candidate
University of Michigan